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FDA 510(k)

EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)

K-Number: K955286 · 1996-05-17

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.
Decision Date1996-05-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-05-17 under 510(k) number K955286. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)?

EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) is a medical device that received FDA 510(k) clearance on 1996-05-17. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K955286.

When did EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) receive FDA 510(k) clearance?

EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) received FDA 510(k) clearance on 1996-05-17, under 510(k) number K955286.

Who is the listed applicant for EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)?

The FDA 510(k) record lists Johnson & Johnson Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)?

The FDA product code for EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) is CGA.

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Other records listing Johnson & Johnson Clinical Diagnostics, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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